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Original Article

Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01)†

An open-label, phase 3 trial

  1. Jong-Mu Sun MD1,
  2. Ki Hyeong Lee MD2,‡,
  3. Sang-we Kim MD3,
  4. Dae Ho Lee MD3,
  5. Young Joo Min MD4,
  6. Hwan Jung Yun MD5,
  7. Hoon Kyo Kim MD6,
  8. Hong Suk Song MD7,
  9. Yeul Hong Kim MD8,
  10. Bong-Seog Kim MD9,
  11. In Gyu Hwang MD10,
  12. Keehyun Lee MD11,
  13. Sook Jung Jo MD12,
  14. Jae Won Lee MD1,2,
  15. Jin Seok Ahn MD1,
  16. Keunchil Park MD1,
  17. Myung-Ju Ahn MD, PhD1,§,*,
  18. for the Korean Cancer Study Group (KCSG)1

Article first published online: 6 JUN 2012

DOI: 10.1002/cncr.27630

Issue

Cancer

Cancer

Volume 118, Issue 24, pages 6234–6242, 15 December 2012

Additional Information

How to Cite

Sun, J.-M., Lee, K. H., Kim, S.-w., Lee, D. H., Min, Y. J., Yun, H. J., Kim, H. K., Song, H. S., Kim, Y. H., Kim, B.-S., Hwang, I. G., Lee, K., Jo, S. J., Lee, J. W., Ahn, J. S., Park, K., Ahn, M.-J. and for the Korean Cancer Study Group (KCSG) (2012), Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01). Cancer, 118: 6234–6242. doi: 10.1002/cncr.27630

Author Information

  1. 1

    Department of Medicine, Samsung Medical Center, Seoul, Korea

  2. 2

    Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea

  3. 3

    Department of Medical Oncology, Asan Medical Center, Seoul, Korea

  4. 4

    Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea

  5. 5

    Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea

  6. 6

    Department of Internal Medicine, The Catholic University of Korea St. Vincent's Hospital, Suwon, Korea

  7. 7

    Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea

  8. 8

    Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea

  9. 9

    Department of Internal Medicine, Seoul Veterans Hospital, Seoul, Korea

  10. 10

    Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea

  11. 11

    Department of Internal Medicine, The Catholic University of Korea Bucheon St. Mary's Hospital, Seoul, Korea

  12. 12

    Department of Internal Medicine, Korea University, Seoul, Korea

  1. §

    Fax: +82-2-3410-1754

*Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong Gangnam-gu, Seoul, 135-710, Korea

  1. †

    The first 2 authors contributed equally to this work.

  2. §

    Fax: +82-2-3410-1754

Publication History

  1. Issue published online: 3 DEC 2012
  2. Article first published online: 6 JUN 2012
  3. Manuscript Accepted: 3 APR 2012
  4. Manuscript Revised: 30 MAR 2012
  5. Manuscript Received: 14 FEB 2012

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Keywords:

  • gefitinib;
  • pemetrexed;
  • nonsmall cell lung cancer

Abstract

BACKGROUND:

Gefitinib was compared with pemetrexed as second-line therapy in a clinically selected population previously treated with platinum-based chemotherapy.

METHODS:

A phase 3 trial of gefitinib (250 mg/day) versus pemetrexed (500 mg/m2 on day 1, every 3 weeks) was conducted in patients who had never smoked and who had advanced pulmonary adenocarcinoma treated with 1 previous platinum-based regimen. The primary endpoint was progression-free survival (PFS).

RESULTS:

A total of 135 patients were analyzed. The gefitinib group had significantly longer PFS compared with the pemetrexed group, with a median PFS time of 9.0 versus 3.0 months (P = .0006). The objective response rates were 58.8% and 22.4% for gefitinib and pemetrexed, respectively (P < .001). However, there was no statistically significant difference in overall survival between the 2 groups (22.2 vs 18.9 months; P = .37). The difference of PFS was increased in a subgroup analysis of 33 patients with activating epidermal growth factor receptor mutation (15.7 vs 2.9 months; hazard ratio, 0.3; 95% confidence interval, 0.13-0.72; P = .005), with numerical superiority of gefitinib in the 38 patients testing negative for epidermal growth factor receptor mutation (5.9 vs 2.7 months; P = .099). Both regimens were well tolerated. There were no significantly different changes in quality of life between the 2 groups, except that symptom scores for dyspnea and diarrhea favored the gefitinib and pemetrexed arms, respectively.

CONCLUSIONS:

Gefitinib showed superior efficacy to pemetrexed as second-line therapy in Korean never-smokers with pulmonary adenocarcinoma. Cancer 2012. © 2012 American Cancer Society.

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